[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"microsurgery\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:microsurgery":28},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,7,0,[8,43,78,101,112,158,179],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":24,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":31,"lastUpdatePostDateStruct":32,"startDateStruct":35,"completionDateStruct":37,"leadSponsor":39,"locationsCount":42},"100053425","a-post-market-real-world-experience-expanding-access-to-care-by-incorporating-the-symani-surgical-system-and-enabling-surgeons-100053425",false,"NCT06725030","A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons","PRECISE: A Post-market, Real-world Experience: Expanding Access to Care by Incorporating the Symani® Surgical System and Enabling Surgeons","PRECISE","Pre Operative Inclusion Criteria:\n\n1. At least 22 years of age\n2. Patient agrees to participate in the study, return for all required follow-up visits, complete all study procedures, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n3. Patient has a clinical indication for a microsurgical anastomosis of vessels between 0.1 and 2.5 mm in conjunction with open free-flap surgery of the breast or extremities and\u002For lymphovenous anastomosis surgery of the extremities\n4. Investigator deems the candidate acceptable for free flap transfer surgery and\u002For lymphovenous anastomosis surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System's Instructions for Use (IFU)\n\nCohort Specific Pre- Operative Inclusion Criteria:\n\nFree Tissue Transfer Surgery: N\u002FA\n\nLymphovenous Anastomosis Surgery\n\n1. Swelling of one limb that is not completely reversed by elevation or compression\n2. Stage I-II lymphedema at screening, based on the International Society of Lymphology (ISL) staging system\n3. At least one of the following positive quantitative measurements:\n\n   1. Volumetry differential between affected limb and contralateral limb must be at least 10% of the other\n   2. Bioimpedance (L-Dex) differential, if feasible, between affected limb and contralateral limb of at least 10 units\n4. Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines, for at least 12 weeks prior to screening, including use of compression garments for at least 12 weeks without change in regimen\n5. Willingness to comply with recommended regimen of self-care, with consistent use of appropriately sized compression garments from screening through the entire study duration (through the 3-month follow-up visit).\n\nPre-Operative Exclusion Criteria:\n\n1. Patients who are incapable and\u002For unwilling to provide informed consent\n2. Active systemic infection under treatment with intravenous antibiotics\n3. Clinically significant cardiovascular, digestive, respiratory, endocrine, or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion\n4. Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n5. Patients with implanted pacemaker\n6. Planned vein graft\n7. Currently receiving chemotherapy or radiation therapy\n8. History of chronic kidney disease\n9. History of chronic liver disease\n10. Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n11. Patients belonging to vulnerable populations, such as pregnant women, or ineligible to participate for other reasons in the judgement of the investigator\n\nCohort Specific Pre-Operative Exclusion Criteria:\n\nFree Tissue Transplant Surgery:\n\n1. Patients with buried flaps\n2. Multiple flaps planned for the procedure\n\nLymphovenous Anastomosis Surgery:\n\n1. Patients \\> 75 years of age\n2. Patients with prior lymphatic reconstruction surgery\n3. Patients with venous edema (arising from increased capillary filtration)\n4. Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n5. Patients with other medical conditions that could result in symptoms which overlap symptoms of lymphedema\n6. Current infection in the affected limb\n7. Patients who experience more than one episode of cellulitis in a six month period over the past two years\n8. Current evidence or a history of malignancy within the past 6 months (if the participant has undergone cancer treatment, this must have been completed \\> 6 months prior to enrollment)\n9. Known iodine sensitivity\n10. Patient's lymphatic disease is due to lipedema\n11. Patients with bilateral lymphedema or lymphedema in multiple anatomical locations\n\nIntra Operative Exclusion Criteria:\n\n1. Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest\n2. The patient does not have at least one robotic stitch attempted during the index procedure","ALL","22 Years",{"count":20,"type":21},455,"ESTIMATED","OBSERVATIONAL","The objective of this study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphovenous anastomosis surgery.\n\nThe primary endpoints are:\n\n* Effectiveness- Rate of intraoperative anastomosis patency at first attempt.\n* Safety- Freedom from device-related adverse events.\n\nParticipants will receive treatment as standard of care and be asked to:\n\n* Allow the researchers to access and use their information.\n* If participants are undergoing a lymphedema procedure, they will be asked to undergo a questionnaire as part of the study.\n* Participants will be asked to comply with the follow-up visits and complete all study procedures\u002Fquestionnaires as outlined in the protocol.",[25,26,27,28,29],"Open Surgery","Lymphedema","Free Tissue Transfer","Microsurgery","Anastomosis, Surgical","RECRUITING","2026-07-10",{"date":33,"type":34},"2026-07-13","ACTUAL",{"date":36,"type":34},"2025-09-22",{"date":38,"type":21},"2027-12-01",{"name":40,"class":41},"MMI (Medical Microinstruments, Inc.)","INDUSTRY",6,{"id":44,"slug":45,"hasResults":11,"nctId":46,"briefTitle":47,"officialTitle":48,"acronym":49,"eligibilityCriteria":50,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":52,"targetDuration":4,"studyType":54,"phases":55,"briefSummary":57,"conditions":58,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":70,"completionDateStruct":72,"leadSponsor":74,"locationsCount":77},"100643524","phase-4-comparing-intraoperative-indocyanine-green-fluorescence-imaging-with-standard-clinical-assessment-for-flap-perfusion-in-head-and-neck-reconstruction-vision-trial-100643524","NCT07635420","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction (VISION Trial)","Comparing Intraoperative Indocyanine Green Fluorescence Imaging With Standard Clinical Assessment for Flap Perfusion in Head and Neck Reconstruction: A Randomised Controlled Trial (VISION Trial)","VISION","Inclusion Criteria:\n\n* Age ≥18 years at the time of inclusion\n* Scheduled to undergo microvascular free flap reconstruction as part of oncologic, trauma, or benign surgery in the head and neck area\n* Ability to understand study information and provide written informed consent\n\nExclusion Criteria:\n\n* Known allergy to indocyanine green or iodine\n* Severe hepatic or renal impairment\n* Confirmed or suspected pregnancy\n* Breastfeeding","18 Years",{"count":53,"type":21},244,"INTERVENTIONAL",[56],"PHASE4","This is a prospective multicentre randomised controlled trial evaluating whether intraoperative indocyanine green (ICG) fluorescence angiography improves outcomes in head and neck free flap reconstruction compared with standard clinical assessment of flap perfusion. Adult patients undergoing microvascular free flap reconstruction for oncologic, trauma, or benign head and neck defects will be randomised to either intraoperative ICG angiography or conventional clinical perfusion assessment. The primary outcome is partial flap loss requiring intervention within 30 days after surgery. Secondary outcomes include total flap loss, flap-related re-exploration, flap salvage, and postoperative complications.",[59,60,61,62,63,64,28,65],"Head and Neck Cancer (H&N)","Free Tissue Flaps","Free Flap","Free Flap Evaluation","Indocyanine Green","Indocyanine Green (ICG)","Randomised Controlled Trial","NOT_YET_RECRUITING","2026-06-08",{"date":69,"type":34},"2026-06-09",{"date":71,"type":21},"2026-10-01",{"date":73,"type":21},"2029-08-01",{"name":75,"class":76},"Region Skane","OTHER",1,{"id":79,"slug":80,"hasResults":11,"nctId":81,"briefTitle":82,"officialTitle":83,"acronym":84,"eligibilityCriteria":85,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":86,"enrollmentInfo":87,"targetDuration":4,"studyType":54,"phases":89,"briefSummary":91,"conditions":92,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":93,"lastUpdatePostDateStruct":94,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":77},"100582660","connect-a-multi-cohort-prospective-investigation-of-the-symani-surgical-system-100582660","NCT06866197","CONNECT: A Multi-Cohort, Prospective Investigation of the Symani® Surgical System","A Multi-Cohort, Prospective Investigation of the Symani® Surgical System: A Novel Approach to the Next Frontier of Microsurgery and Expanding Access to Care in Free Tissue Transfer and Lymphatic Surgery","CONNECT","Inclusion Criteria:\n\n* Adults, according to the local law\n* Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n* Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and\u002For lymphatic surgery Investigator considers candidate acceptable for free flap transfer surgery and\u002For lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU\n\nInclusion Criteria for Therapeutic Lymphatic Patients:\n\n* For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)\n* For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):\n\n  1. Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other\n  2. Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units\n* Maintain complete decongestive therapy (CDT), according to International Society of Lymphology (ISL) guidelines, for a minimum duration of four (4) weeks prior to screening\n* Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration\n* Patient must be diagnosed with Lymphedema\n* Patient must have a body mass index (BMI) of ≤ 35\n\nInclusion Criteria for Prophylactic Lymphatic Patients:\n\n* The patient has at least one identifiable risk factor for developing lymphedema of the extremities\n* Patient with a body mass index (BMI) of ≤ 35\n\nExclusion Criteria:\n\n* Patients who are not capable and\u002For unwilling to provide informed consent\n* Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.\n* Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n* Patients with implanted pacemaker\n* Planned vein graft (either venous or arterial)\n* Previously documented history of chronic kidney disease (eGFR ≤ 30)\n* Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n* Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator\n\nExclusion Criteria for Free Tissue Transfer Patients:\n\n* Patients with buried flaps\n* Multiple flaps planned for the procedure\n\nExclusion Criteria for Therapeutic Lymphatic Patients:\n\n* Patients with venous edema (arising from increased capillary filtration)\n* Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n* Current infection in the affected area of lymphedema\n* Current evidence of malignancy\n* Known iodine sensitivity\n* Patient's lymphatic disease is due to lipedema\n* Patients with bilateral lymphedema or lymphedema in multiple anatomical locations\n\nExclusion Criteria for Prophylactic Lymphatic Participants:\n\n* Patients for whom prophylactic surgery on more than one limb is planned\n* Known iodine sensitivity\n* Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator\n* Patients diagnosed with lymphedema\n\nIntraoperative Exclusion Criteria:\n\n* Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest\n* The patient does not have at least two robotic sutures attempted during the index procedure","100 Years",{"count":88,"type":21},180,[90],"NA","The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery.\n\nThe primary endpoints are:\n\nEffectiveness: Clinical Success, defined as intraoperative anastomosis patency. Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.\n\nParticipants will receive treatment as standard of care and be asked to:\n\nAllow the researchers to access and use their information. If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments.\n\nParticipants will be asked to comply with the follow-up visits as outlined in the protocol.",[28,26,27],"2026-03-27",{"date":95,"type":34},"2026-04-02",{"date":97,"type":34},"2026-01-20",{"date":99,"type":21},"2029-01-20",{"name":40,"class":41},{"id":102,"slug":4,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":103,"targetDuration":4,"studyType":22,"phases":4,"briefSummary":23,"conditions":104,"keywords":4,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":105,"lastUpdatePostDateStruct":106,"startDateStruct":108,"completionDateStruct":109,"leadSponsor":110,"locationsCount":111},"100571805",{"count":20,"type":21},[25,26,27,28,29],"2026-03-04",{"date":107,"type":34},"2026-03-05",{"date":36,"type":34},{"date":38,"type":21},{"name":40,"class":41},4,{"id":113,"slug":114,"hasResults":11,"nctId":115,"briefTitle":116,"officialTitle":117,"acronym":118,"eligibilityCriteria":119,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":120,"enrollmentInfo":121,"targetDuration":4,"studyType":54,"phases":123,"briefSummary":124,"conditions":125,"keywords":136,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":147,"lastUpdatePostDateStruct":148,"startDateStruct":150,"completionDateStruct":152,"leadSponsor":154,"locationsCount":157},"100592462","effect-of-dexmedetomidine-on-microsurgery-reconstruction-in-cancer-patient-100592462","NCT06993740","Effect of Dexmedetomidine on Microsurgery Reconstruction in Cancer Patient","The Effect of Dexmedetomidine Administration on the Success of Reconstructive Microsurgery in Cancer Patients: A Study of Glycocalyx Integrity, Inflammatory Response, Thrombosis, Angiogenesis, Oxidative Stress, and Tissue Microcirculation","DEXFLAP","Inclusion Criteria:\n\n1. Adult patients (aged 18-65 years) diagnosed with cancer who are scheduled to undergo microsurgical flap reconstruction.\n2. Patients within the age range of 18 to 65 years at the time of enrollment.\n3. Patients who provide written informed consent to participate in the study.\n\nExclusion Criteria:\n\n1. Patients with a history of uncontrolled diabetes mellitus.\n2. Patients diagnosed with chronic kidney disease.\n3. Patients with known liver failure.\n4. Patients receiving corticosteroid therapy prior to surgery.\n5. Patients with uncontrolled hypertension.\n6. Patients with a history of chemotherapy or radiotherapy prior to surgery.\n7. Patients diagnosed with preoperative sepsis.\n8. Patients requiring perioperative vasopressor support.\n9. Patients with a history of prior surgery in the same operative field.\n10. Patients who decline to participate in the study.","65 Years",{"count":122,"type":21},60,[90],"This double-blinded randomized controlled trial aims to investigate the effect of intraoperative dexmedetomidine administration on early flap viability and microvascular integrity in cancer patients undergoing elective microvascular reconstructive surgery. The primary outcome is clinical flap viability within 48 hours postoperatively, assessed using a standardized scoring system based on flap color, temperature, capillary refill time, and tissue turgor. Secondary outcomes include the evaluation of biomarkers related to endothelial glycocalyx degradation (syndecan-1), oxidative stress (SOD-1), inflammation (IL-6, IL-10), thrombosis (PAI-1), and angiogenesis (VEGF), as well as microcirculatory assessment using Sidestream Dark Field (SDF) imaging. The study is designed to determine whether dexmedetomidine improves early surgical outcomes by modulating pathophysiological processes involved in microvascular flap success.",[126,127,128,129,130,131,132,133,134,135,28],"Flap Monitoring","Inflammation","Thrombosis","Oxidative Stress","Glycocalyx","Anesthesia","Surgery","Flap Ischemia","Flap Necrosis","Flap Failure Risk Factors",[137,138,139,140,141,142,143,144,145,146],"SOD-1","IL-6","IL-10","VEGF","Syndecan-1","Dexmedetomidine","SDF","PAI-1","Flap Failure","Flap Salvage","2025-06-11",{"date":149,"type":34},"2025-06-15",{"date":151,"type":34},"2025-06-10",{"date":153,"type":21},"2026-08-22",{"name":155,"class":156},"Dharmais National Cancer Center Hospital","OTHER_GOV",2,{"id":159,"slug":160,"hasResults":11,"nctId":161,"briefTitle":162,"officialTitle":163,"acronym":164,"eligibilityCriteria":165,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":166,"targetDuration":4,"studyType":54,"phases":168,"briefSummary":169,"conditions":170,"keywords":4,"overallStatus":66,"whyStopped":4,"lastUpdateSubmitDate":171,"lastUpdatePostDateStruct":172,"startDateStruct":174,"completionDateStruct":176,"leadSponsor":178,"locationsCount":4},"100564364","a-global-prospective-real-world-investigation-of-the-symani-surgical-system-for-microsurgical-anastomosis-100564364","NCT06628219","A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis","A Global, Prospective, Real-World, Investigation of the Symani® Surgical System for Microsurgical Anastomosis: Expanding Access to Care in Free Tissue Transfer Surgery and Lymphatic Surgery","PRIME","Inclusion Criteria:\n\n* Adults, according to the local law\n* Patient agrees to participate in the study, return for all required follow-up visits, and has willingly provided written informed consent after receiving all information related to the study, its requirements, and the robotic assisted procedure\n* Patient with a clinical indication for a microsurgical anastomosis for a free flap transfer surgery and\u002For lymphedema surgery\n* Investigator considers candidate acceptable for free flap transfer surgery and\u002For lymphatic surgery with a robotic assisted microsurgical anastomosis in accordance with the Symani System IFU\n\nInclusion Criteria for Therapeutic Lymphatic Patients:\n\n* For lymphedema of the extremities, swelling of lymphedema that is not completely reversed by decongestion therapy modalities. (Not applicable for patients with lymphedema of the head and neck)\n* For lymphedema of the extremities, at least one of the following positive quantitative measurements (not applicable for patients with lymphedema of the head and neck):\n\n  1. Volumetry differential between diseased limb and contralateral limb must be at least 10% of the other\n  2. Bioimpedance (L-Dex) differential, if feasible, between diseased limb and contralateral limb of at least 10 units\n* Completion of a full course of complete decongestive therapy (CDT), according to ISL guidelines at least 12 weeks prior to screening\n* Willingness to comply with recommended regimen of self-care, with consistent use of compression garments from screening through the entire study duration\n* Patient must be diagnosed with Lymphedema\n* Patient must have a body mass index (BMI) of ≤ 35\n\nInclusion Criteria for Prophylactic Lymphatic Patients:\n\n* In the opinion of the investigator, the patient has at least one identifiable indication for prophylactic lymphatic surgery.\n* Patient must have a body mass index (BMI) of ≤ 35\n\nExclusion Criteria:\n\n* Patients who are not capable and\u002For unwilling to provide informed consent\n* Clinically significant cardiovascular, digestive, respiratory, endocrine, liver or central nervous system disorders, previous mental disorders, or other disorders that may significantly affect the data collection or the ability to comply with the protocol per the investigators discretion.\n* Known history of significant bleeding, coagulopathy, or Von Willebrand's disease\n* Patients with implanted pacemaker\n* Planned vein graft (either venous or arterial)\n* Previously documented history of chronic kidney disease (eGFR ≤ 30)\n* Currently enrolled in any other investigational clinical studies that the investigator believes may impact patient safety or outcomes\n* Patients belonging to vulnerable populations, such as pregnant women, or patients ineligible to participate for other reasons in the judgement of the investigator\n\nExclusion Criteria for Free Tissue Transfer Patients:\n\n* Patients with buried flaps\n* Multiple flaps planned for the procedure\n\nExclusion Criteria for Therapeutic Lymphatic Patients:\n\n* Patients with venous edema (arising from increased capillary filtration)\n* Patients with other medical conditions that could lead to acute limb edema, such as (but not limited to) acute venous thrombosis or heart failure\n* Current infection in the affected area of lymphedema\n* Current evidence of malignancy\n* Known iodine sensitivity\n* Patient's lymphatic disease is due to lipedema\n* Patients with bilateral lymphedema or lymphedema in multiple anatomical locations\n\nExclusion Criteria for Prophylactic Lymphatic Participants:\n\n* Patients for whom prophylactic surgery on more than one limb is planned\n* Known iodine sensitivity\n* Patients with post-thrombotic syndrome, arterial insufficiency, deep vein thrombosis or any other medical condition that could make them ineligible to participate in the judgment of the investigator\n* Patients diagnosed with lymphedema\n* Patients who have received prior radiation therapy to the affected limb where the investigator believes the amount or extent of radiation could compromise the success of prophylactic lymphatic surgery\n\nIntraoperative Exclusion Criteria:\n\n* Any presenting condition discovered intraoperatively that, in the opinion of the investigator, would make participating in this study not in the patient's best interest\n* The patient does not have at least two robotic sutures attempted during the index procedure",{"count":167,"type":21},1000,[90],"The objective of this clinical study is to evaluate the Symani System's safety and effectiveness for microsurgical anastomosis during free tissue transfer surgery and lymphatic surgery.\n\nThe primary endpoints are:\n\n* Effectiveness: Clinical Success, defined as intraoperative anastomosis patency.\n* Safety: Freedom from device-related serious adverse events prior to discharge from the index hospitalization, as adjudicated by a Clinical Events Committee.\n\nParticipants will receive treatment as standard of care and be asked to:\n\n* Allow the researchers to access and use their information.\n* If participants are undergoing a therapeutic lymphatic procedure, they will be asked to complete a questionnaire and undergo lymphedema volume assessments as part of the study. If participants are undergoing a prophylactic lymphatic procedure, they will only be asked to undergo limb volume assessments.\n* Participants will be asked to comply with the follow-up visits as outlined in the protocol.",[25,26,27,28],"2024-12-05",{"date":173,"type":34},"2024-12-10",{"date":175,"type":21},"2025-02-01",{"date":177,"type":21},"2030-02-01",{"name":40,"class":41},{"id":180,"slug":181,"hasResults":11,"nctId":182,"briefTitle":183,"officialTitle":184,"acronym":4,"eligibilityCriteria":185,"healthyVolunteers":11,"sex":17,"minAge":51,"maxAge":4,"enrollmentInfo":186,"targetDuration":4,"studyType":54,"phases":188,"briefSummary":189,"conditions":190,"keywords":196,"overallStatus":30,"whyStopped":4,"lastUpdateSubmitDate":204,"lastUpdatePostDateStruct":205,"startDateStruct":207,"completionDateStruct":209,"leadSponsor":211,"locationsCount":77},"100569432","efficacy-of-the-entire-papilla-preservation-technique-with-and-without-the-use-of-l-prf-as-a-regenerative-material-for-the-treatment-of-infrabony-defects-100569432","NCT06694168","Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects","Efficacy of the Entire Papilla Preservation Technique With and Without the Use of L-PRF as a Regenerative Material for the Treatment of Infrabony Defects: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* Patients diagnosed with periodontal disease (loss of interproximal clinical attachment loss in 2 non-adjacent teeth or clinical attachment loss of ≥3mm associated with a PD \\>3 mm in two or more teeth) will be included.\n* After re-evaluation (6 weeks after non-surgical periodontal therapy) presented residual probing depths equal to or greater than 6 mm.\n* Residual pocket is associated with interproximal intrabony periodontal defects of at least 2 walls, with a depth ≥ 3 mm and an angulation ≤ 40º determined on a periapical radiograph.\n\nExclusion Criteria:\n\n* Patients with an underlying decompensated pathology such as diabetes and hypertension.\n* Patients taking medications that interfere with the healing process such as bisphosphonates.\n* Patients with diseases that alter bone metabolism such as osteoporosis.\n* Pregnant or breastfeeding women.",{"count":187,"type":21},30,[90],"The goal of this clinical trial is to evaluate the efficacy of using L-PRF (leukocyte and platelet rich fibrin clot) as an autologous filling material in conjunction with the EPP (entire papilla preservation) technique for the treatment of interproximal intraosseous periodontal defects, compared to the same technique without L-PRF regarding clinical periodontal parameters and obtained radiographic parameters. It will also report possible postoperative complications and evaluate postoperative sensitivity. The main questions it aims to answer is:\n\n• What is the effectiveness of LPR-F in conjunction with a complete papilla preservation (EPP) technique for the treatment of intrabony periodontal defects in CESA (health care center) patients in terms of clinical and radiographic periodontal parameters compared to the use of the same technique without L-PRF?\n\nA non-randomized controlled clinical trial will be conducted on patients at CESA of the Universidad de los Andes. In 30 patients, 30 periodontal defects associated with a pocket with probing depths equal to or greater than 6 mm will be treated using the complete papilla preservation technique, either with L-PRF filling or without any filling material, assigned randomly to each intervention (15 participants in each group). Researchers will evaluate clinical and radiographic parameters at baseline and 6 months post-surgery. Patients will report their level of pain 24 hours and 7 days after surgery.",[191,192,193,28,194,195],"Periodontal Regeneration","Minimally Invasive Surgical Technique","Platelet Rich Fibrin","Periodontal Intrabony Defect","Periodontal Disease",[197,198,28,199,200,201,202,203],"Periodontitis","Guided Tissue Regeneration","Bone Regeneration","Treatment Outcome","Intrabony defect","minimally invasive surgical technique","Entire papilla preservation","2024-11-20",{"date":206,"type":34},"2024-11-25",{"date":208,"type":34},"2024-08-27",{"date":210,"type":21},"2026-06-30",{"name":212,"class":76},"Universidad de los Andes, Chile"]